General obligations for authorised representatives of medical devices
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Authorised representative is any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf.
What requirements apply to an authorised representative?
The table below lists some of the requirements, but the list is not exhaustive. Requirements and obligations for authorised representatives are found in several parts of MDR and IVDR and it is important that authorised representatives familiarise themselves with the entire regulations.
Article | Overview of some of the requirements |
MDR Article 11 IVDR Article 11 |
General requirements for:
An authorised representative, together with the manufacturer, is legally responsible for defective devices. |
MDR Article 11 IVDR Article 11 |
Requirements for replacing an authorised representative |
MDR Article 15 IVDR Article 15 |
Requirement for person responsible for regulatory compliance |
MDR Article 31 IVDR Article 28 |
Requirements for registration of authorised representatives and single registration number |
MDR Article 95 IVDR Article 90 |
Requirement for procedure for dealing with devices presenting an unacceptable risk to health and safety |
Overview of the different roles of economic operators:
Economic operator |
Definition in MDR Article 2 and IVDR Article 2 |
Manufacturer | A natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. |
Authorised representative | Any natural or legal person established within the Union* who has received and accepted a written mandate from a manufacturer, located outside the Union*, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation. |
Importer | Any natural or legal person established within the Union* that places a device from a third country on the Union* market. |
Distributor | Any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service. |
Health institution | An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health. |